The present invention relates generally to a method of external genital cleansing using a prophylactic kit and more specifically to a combination of one or more condoms and one or more wipes as the kit and the method of use of combinations of these articles for purposes of external genital cleansing intended to enhance hygiene and thereby reduce the possibility of infection by sexually transmitted diseases (STDs) particularly including the Human Immunodeficiency Virus (HIV).
It is generally understood that safe sex is the practice of intimate human sexual intercourse with safeguards placed with the intent of minimizing the transmission of a number of diseases that can occur from such intimate contact with an infected partner. Accordingly, substantive hygienic precautions are necessary components of preserving the health of either partner in the practice of safe sex. In addition to the cleansing of genitals and the absence of open wounds about the genital area, a condom is commonly used as an effective physical barrier for the prevention of both (a) conception and (b) the transmission of microbes through skin or mucosal contact between partners or through the exchange of seminal and vaginal fluids. Also commonly used in the practice of safe sex are vaginal applications of various preparations with either spermicidal or lubricating properties, or both.
Acquired Immune Deficiency Syndrome (AIDS) is a severe immunological disorder that is the final and most serious stage of the HIV disease. The retrovirus, HIV, causes a defect in the cell-mediated immune response that is manifested by increased susceptibility to opportunistic infections and to certain rare cancers, especially Kaposi""s sarcoma. HIV can be transmitted via blood transfusions, the sharing of injection needles, through a pregnant or nursing mother to her child, and, in rare instances, through donated semen and organs and through accidental needle sticks. That being said, HIV is transmitted primarily via venereal routes. That is, the chief way of transmitting HIV is through unsafe sexual contact with an infected partner. HIV can be found in the saliva, tears, nervous system tissue, blood, semen (including pre-seminal fluid), vaginal fluid, and breast milk of an infected person. However, only blood, semen, vaginal secretions, and breast milk have been proven to transmit the infection to others.
Recent medical research casts doubt on the effectiveness of the topical microbicide nonoxynol-9 when used in the vagina or rectum to prevent HIV transmission in humans. The irritating side effect nonoxynol-9 has on the mucosal tissues of the vagina and rectum appears to create opportunities for HIV infection. The research teaches away from the use of irritating topical microbicides such as povidone-iodine solutions and nonoxynol-9 where in practical use, they are expected to enter the vagina or rectum preceding or during sexual activity. Moreover, the results of the research indicate that the use of nonirritating, over-the-counter lubricants should be considered for human field trials in the inhibition of HIV production. (See, for example, S. Baron, J. Poast, D. Nguyen, and M. W. Cloyd, xe2x80x9cPractical Prevention of Vaginal and Rectal Transmission of HIV by Adapting the Oral Defense: Use of Commercial Lubricants,xe2x80x9d AIDS Research and Human Retroviruses, Volume 17, Number 11, 2001, pp. 997-1002.)
Presently, most retail pharmacies and a great number of grocery and general retail stores offer hygienic wipes along with vaginal lubricants with advertising and trade dress particularly targeting the female consumer. These wipes are individually packaged and sold over the counter in bulk quantities and are designed to be used to clean the substantially external portions of the female genital region. These wipes may also contain microbicides such as nonoxynol-9. These wipes are packaged so as to remain moist within the package and may be scented. One uses the wipes by opening the package, unfolding the wipe, and then applying the wipe as one does a towelette.
It is generally understood that a condom is as a flexible sheath, usually made of thin rubber or latex, designed to cover the penis during sexual intercourse and is worn either for contraceptive purposes or as a barrier device for preventing sexually transmitted diseases, or both. Most condoms are individually packaged and may be obtained with a pre-coating of a spermicidal lubricant. Latex condoms have been shown to be an effective barrier to the transmission of STDs including HIV. That is, if properly applied and properly removed, the use of condoms alone works to prevent sexually transmitted diseases specifically during intercourse. A problem arises in collateral contact of those surfaces or fluids not protected or blocked by the condom barrier. An additional problem arises in that sexual activity before, during, and after intercourse can include a variety of acts beyond coitus. These acts of intimate sexual contact may also give rise to increasing the risk of transmitting STDs including HIV.
U.S. Pat. Nos. 4,925,033 and 5,244,096 to F. L. Stoner disclose a kit for the cleaning of the genital region before and after intercourse principally with povidone-iodine solution, and the cleaning of the mouth with a mouthwash and a toothbrush. While Stoner discloses the application of povidone-iodine solution with a towelette, Stoner does not disclose the inclusion of one or more wipes containing a povidone-iodine solution as part of the kit. In addition, while Stoner discloses the inclusion of a detergent with the povidone-iodine solution, Stoner does not anticipate the irritating effects of the solution on mucosal tissues collaterally contacted in the cleaning process; irritating effects that work against HIV transission.
An object of the present invention is to provide for the convenient cleansing of the external genital region with wipes of selected solutions accompanied by use of one or more included condoms and, through the use of the prophylactic kit contents, thereby reduce the risk of STD, and particularly HIV, transmission. Thus, from the perspective of ease of use, the knowledge of the irritating qualities of povidone-iodine, and the research indicating that human saliva is effective in the natural inhibition of HIV transmission through the targeting of the transmitting infected leukocytes and any cell-fee HIV in seminal fluids, a mouthwash and toothbrush are neither needed nor applied in the present invention.
There remains the need for a condom and one or more hygienic wipes that are conveniently packaged together; the contents of which can be used before and after sexual contact to prevent transmission of STDs, particularly including HIV, while cleaning the genital region with minimal irritation.
The present invention satisfies that need with a method of genital cleansing and prophylactic kit comprised of a one or more first wipes containing an over-the-counter, nonirritating lubricant such as Vagisil(copyright) Intimate Moisturizer, Astroglide(copyright) Personal Lubricant or ViAmor(copyright) Vaginal Moisturizer disposed on or impregnated therein and one or more second wipes preferably containing water-based glycerol and nonoxynol-9 disposed on or impregnated therein for controlled solution application. The user may use a second wipe, or a first wipe, or both in succession, to cleanse the genital region topically in advance of sexual contact and the application of one or more condoms. After the application of one or more condoms, the completion of male climax, and the removal of the one or more condoms, the genital region may then be cleansed with a first wipe or second wipe or both in succession, preferably a second wipe followed by a first wipe. In all cases, while the second wipe may be used optionally, the first wipe is to be used for effective HIV inhibition in the maintenance of genital hygiene with minimal irritation to mucosal tissues affected by collateral contact in the cleaning process. Where wash facilities may not be readily available, a third wipe may be used that is comprised of sterile water or a non-irritating, sterile water-based solution for mild, nonirritating cleansing.
A method of external genital cleansing and prophylactic kit are disclosed. The kit includes wipes having an over-the-counter lubricant such as Vagisil(copyright) Intimate Moisturizer, Astroglide(copyright) Personal Lubricant or ViAmor(copyright) Vaginal Moisturizer disposed on or impregnated therein. The wipes may be individually packaged and placed with a packaged latex condom as a kit. Where extensive external cleansing may be required, the kit may also include wipes preferably having water-based glycerol and nonoxynol-9 disposed on or impregnated therein. Where wash facilities may not be readily available, a third wipe that is comprised of sterile water or a non-irritating, sterile water-based solution may be included in the kit. The invention further comprises the method by which the contents of the prophylactic kit are used.